<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2018</study_start_year><data_sharing_plan>IPD Sharing (as of October 2023): No
Description: Availability of this study’s data will later be determined according to Bayer’s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.</data_sharing_plan><condition>Metastatic Colorectal Cancer</condition><condition>Colorectal Neoplasms</condition><disease>Metastatic Colorectal Cancer</disease><disease>Colorectal Neoplasms</disease><study_type>Interventional</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2275981</full_dataset_link><location>India</location><study_start_month>7</study_start_month><keyword>MCRC</keyword><repository>ECRIN MDR</repository><study_status>Active, not recruiting</study_status></additional><is_claimable>false</is_claimable><name>Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).</name><description>This is a Phase IV, single-arm, prospective, open-label, multicenter, interventional study to evaluate safety and efficacy of regorafenib in patients with mCRC who have been previously treated with fluoropyrimidine , oxaliplatin-, and irinotecan based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.</description><dates><creation>2018-07-15</creation></dates><accession>2275981</accession><cross_references><ClinicalTrials___gov>NCT03564938</ClinicalTrials___gov></cross_references></HashMap>